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Showing 181–200 of 3363 results

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Just Right 5000 Fluoride (Elevate Oral Care) – Label Mix-up (2024)

LABELING: LABEL MIX-UP.

Class IIILow

FDAAug 20, 2024Nationwide• Elevate Oral Care

Pasteurized Donor Human Milk (Mothers' Milk Bank) – Physical Contaminant (2024)

Potential physical contaminant

Class IIILow

FDAAug 18, 2024AL• Mothers' Milk Bank of Alabama

Varithena Injection Pack (Biocompatibles) – Delivery System Defect (2024)

Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).

Class IIILow

FDAAug 15, 2024Nationwide• Biocompatibles UK, Ltd.

Hydrocortisone Otic Solution (Taro) – Impurity Specification Failure (2024)

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

Class IIILow

FDAAug 7, 2024Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Methotrexate Tablets (Amneal) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

Class IIILow

FDAAug 1, 2024Nationwide• Amneal Pharmaceuticals, LLC

Cornbread Muffins (Frozen Food Processors) – Unsanitary Conditions (2024)

Manufacturing without State License and in unsanitary conditions.

Class IIILow

FDAJul 22, 2024AL, AR, LA +2 more• Frozen Food Processors, Inc.

Jalapeno Cornbread Muffins (Frozen Food Processors) – Unsanitary Conditions (2024)

Manufacturing without State License and in unsanitary conditions.

Class IIILow

FDAJul 22, 2024AL, AR, LA +2 more• Frozen Food Processors, Inc.

Almond Croissant (SSP America) – Undeclared Nuts (2024)

Finished product label stated almond in the product name but did not declare tree nuts or almonds in the ingredients or allergen statement.

Class IIILow

FDAJul 19, 2024AZ• SSP America PHX, LLC

Acetaminophen (Granules) – Label Mix-up (2024)

Label mix-up: Carton incorrectly labeled.

Class IIILow

FDAJul 18, 2024IL, IN• Granules Consumer Health Inc.

Oh Baby BBQ Sauce (Corey B's) – Wheat allergen (2024)

Undeclared Allergen

Undeclared Allergen - Wheat

Class IIILow

FDAJul 11, 2024AL, AK, AZ +46 more• Hoff & Pepper, Co LLC.

Fox's U-bet Vanilla Syrup (SUBCO) – Bloated Bottles (2024)

Customer complaint for bloated bottles. Testing and examination of these lots has revealed they did not meet specifications, including elevated pH and water activity levels. This may be indicative of microbiological activity, and concurrent risk of food-borne illness.

Class IIILow

FDAJul 9, 2024CT, DE, MD +2 more• SUBCO FOODS INC